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Prevention of Post Operative Bone Loss in Children - NCT00655681-87102(Clinical Trial 213402)



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City:  Albuquerque
State:  
NM
Zip Code: 87102
Conditions: Osteoporosis - Cerebral Palsy - Spina Bifida - Osteopenia - Osteogenesis Imperfecta
Purpose: Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.
Study summary: Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group Repeat DXA scan after end of immobilization or non-weightbearing
Criteria: Inclusion Criteria: - chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta - lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks Exclusion Criteria: - creatinine >1.2 - prior bisphosphonate exposure - orthopaedic implants in distal femoral precluding DXA scan - inability to cooperate with DXA scan
Study is available at: University of New Mexico Carrie Tingley Hospital
Albuquerque, NM 87102
United States

Primary Contact:
Elizabeth A Szalay, MD
Email: ESzalay@salud.unm.edu
Phone: 505 272-5214
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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